Phase Ii Study Of Lovastatin To Prevent Rectal Injury From Radiation Therapy For Prostate Cancer.

120 Background: Late radiation induced rectal injury remains an issue. Large population based studies indicate an incidence of at least 15%. Statins have been shown to reduce the risk of late radiation injury in animal models. The purpose of this study was to prospectively test lovastatin as a potential protector against radiation induced rectal injury, particularly bleeding. Methods: Eligible patients included men with adenocarcinoma of the prostate who were to be treated with radiation therapy with curative intent. Patients receiving primary radiation therapy (external beam alone, brachytherapy alone, or a combination of both) or post-prostatectomy radiation were eligible, as long as the minimum dose to the rectum was 60 Gy. Patients began lovastatin 20-80 mg/d on day 1 of radiation. Lovastatin was continued for 1 year and patients were followed for an additional year. Patients were seen at 1, 2, 4, 6, 9, 12, 18, 21 and 24 months after treatment. At each follow-up, they were assessed for GI, GU and erec...